Selected Poster Abstracts From Symposium for Cosmetic Advances & Laser Education (SCALE) 2024

J Clin Aesthet Dermatol. 2024;17(9 Suppl 2):S11–S27.

A message from the Guest Editors and SCALE Program Directors

Dear Colleagues: 

The 2024 Symposium for Cosmetic Advances & Laser Education (SCALE), held in Nashville, Tennessee on May 15 to 19, 2024, saw a variety of clinical and scientific data presented, but not just at the podium; clinically relevant material was also presented in poster format. For those of you who were unable to participate in the meeting or were not able to attend the poster sessions, we have compiled abstracts from a select group of research posters presented during the 2024 meeting. It is our hope that you will find the highlighted research informative and thought provoking.

Michael Gold, MD, and Brian Biesman, MD

SCALE 2024 Program Directors; Guest Editors, The Journal of Clinical and Aesthetic Dermatology

 

 

 

Content

Acne

• Improvement in skin moisturization and lack of barrier damage with clascoterone cream 1% treatment: Results of a randomized, single-blind, split-face study in acne-prone individuals

Aesthetic Practice Insights

• Aesthetic concerns regarding body skin quality: Results from a large survey of aesthetically-inclined adults in the United States 
• Aesthetic concerns regarding facial skin quality: Results from a large survey of aesthetically-inclined adults in the United States 
• Importance of posttreatment follow-up with patients in aesthetic practice
• The burden and psychosocial impact of platysma prominence

Atopic Dermatitis

• A Phase 2b, randomized, double-blind, placebo-controlled, multi-center, global study to evaluate the efficacy and safety of ANB032 in the treatment of subjects with moderate to severe atopic dermatitis 

Energy-based Treatments

• Real-world experience using a multi-modality system that combines intense pulsed light, laser hair removal, high-intensity focused ultrasound, fractional radiofrequency microneedling, and thermal radiofrequency for skin rejuvenation treatment
• Post-procedure cream with unique neurotopical technology improves patient experience and recovery following fractional ablative CO₂ laser treatment
• Novel post-procedure topical treatment enhances patient comfort post-hybrid fractional laser
• Synchronous ultrasound parallel beam technology for acne scars appearance improvement
• Synchronous ultrasound parallel beam technology for cellulite appearance improvement

 

Psoriasis

• Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in plaque psoriasis: 3-year Psoriasis Area and Severity Index outcomes in the long-term extension of the Phase 3 POETYK PSO-1 and PSO-2 trials
• Efficacy of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in Scalp Psoriasis by Baseline Psoriasis Area and Severity Index and Baseline Body Surface Area: A subanalysis of the Phase 3 clinical trial data  
• Quality of life in participants with hyperkeratotic psoriasis treated with combination halobetasol propionate/tazarotene lotion 
• Changes in TNF-α levels in psoriatic plaques after treatment with fixed-combination halobetasol propionate and tazarotene lotion versus clobetasol propionate 0.05% cream
• A systematic literature review and meta-analysis of the real-world effectiveness, quality of life, and safety of tildrakizumab for moderate-to-severe plaque psoriasis

 

Skincare and Cosmeceuticals

• Clinical evaluation of next-generation, multi-weight hyaluronic acid plus antioxidant complex-based topical formulations with targeted delivery to enhance skin rejuvenation
• Significantly enhanced improvement in dryness, roughness, fine lines and radiance following daily use of a novel multi-weight plus antioxidant complex-based lotion compared to a single-weight ha plus ceramide-based lotion
• A multi-action facial night cream containing Macrocystis pyrifera ferment and extracts from Crithmum maritimum and Laminaria digitata delivers ageless benefits over night and over time  
• A complex of three marine extracts exhibits “retinol-like” anti-aging mechanisms without stimulating an acute inflammatory response 
• Evaluation of a skincare regimen comprised of a serum containing plant adaptogens and a cream addressing three components of moisturization pre- and post-laser treatment or a medium-depth chemical peel
• Evaluation of a new moisturizer developed to address three critical elements of natural moisturization in participants with moderate-to-severe dry, dehydrated facial skin.
• Real-world clinical experience with a neuro-peptide serum in combination with neurotoxin injectables 
• Snail extract for skin: A review of uses, projections, and limitations
• The use of Aquaphilus dolomiae ferment filtrate recovery cream with topical corticosteroids, a potential option to mitigate concerns for dermal thinning and barrier disruption 

 

 

ACNE

Improvement in skin moisturization and lack of barrier damage with clascoterone cream 1% treatment: Results of a randomized, single-blind, split-face study in acne-prone individuals

Presenters: Draelos Z,¹ Kyeremateng K,² Squittieri N²

Affiliations: ¹Dermatology Consulting Services, PLLC, High Point, NC; ²Sun Pharmaceutical Industries, Inc., Princeton, NJ

Background: Topical medications commonly prescribed for the treatment of acne vulgaris (eg, benzoyl peroxide, retinoids) may be limited by adverse effects, such as application-site dryness, that can result in skin barrier damage. 

Objective: This study aimed to evaluate changes in skin barrier properties induced by treatment with clascoterone cream 1%, a topical androgen receptor inhibitor approved in the US, Canada, and Australia for the treatment of acne vulgaris, in acne-prone individuals.

Methods: This single-center split-face study enrolled male and female participants ≥18 years old who self-identified as having acne-prone skin. Participants were randomized to treatment with clascoterone cream 1% (approximately 0.5g) twice daily to the right or left side of the face following cleansing for two weeks. Participants were permitted to continue using a self-selected cleanser and sunscreen during the study. The use of topical medications or facial skincare products other than cleanser and sunscreen was prohibited. The primary and secondary endpoints were the change in corneometry reading and change in transepidermal water loss (TEWL), respectively, between the clascoterone-treated and untreated sides of the face. These parameters were assessed at baseline and during the treatment period at 24 hours, Week 1, and Week 2. Tolerability was evaluated by recording the severity of dryness, erythema, scaling, irritation, tightness, stinging, itching, and burning for each side of the face using a five-point scale from 0 (none) to 4 (severe). Nonparametric results were analyzed using Wilcoxon signed rank test or sign test for paired comparisons at different time points, and parametric results were analyzed using paired t-tests.

Results: Of the 50 participants enrolled, 12 were male and 38 were female. Mean±standard deviation (SD) age was 31.1±8.9 (range, 19–45) years and 60 percent of the participants were White. From baseline to Week 2, the mean±SD corneometry reading for the clascoterone-treated side of the face increased from 122.0±37.7 to 131.3±42.9, whereas it decreased for the untreated side from 119.3±39.7 to 113.9±36.6. The difference in corneometry between sides at Week 2 was statistically significant (P<0.001), indicating an improvement in skin moisturization with treatment. There were no differences in mean TEWL between sides of the face at all time points assessed indicating a lack of barrier damage. There were also no differences in any of the tolerability parameters evaluated, most of which had a mean rating of 0 for both sides of the face.

Conclusion: Twice-daily treatment with clascoterone cream 1% for two weeks in individuals with acne-prone skin led to an increase in moisturization and maintenance of skin barrier function as assessed by corneometry and TEWL, and was otherwise well tolerated.

Disclosures: ZD was an investigator on this study. KK and NS are employees of Sun Pharmaceutical Industries, Inc.

Funding: The study and medical writing support for the abstract were funded by Sun Pharma.

 

 AESTHETIC PRACTICE INSIGHTS

Aesthetic concerns regarding body skin quality: Results from a large survey of aesthetically-inclined adults in the United States

Presenters: Fabi S,¹ Alexis A,² Bharti G,³ Bucay V,⁴ Henry M,⁵ Houshmand E,⁶ Ibrahim O,⁷ HR Jalian,⁸ Moradi A,⁹ Zeidler K,¹⁰ Karic A,¹¹ Zheng JN,¹¹ Downie J¹²

Affiliations: ¹Cosmetic Laser Dermatology, San Diego, CA; ²Department of Dermatology, Weill Cornell Medicine, New York, NY; ³H/K/B Cosmetic Surgery, Charlotte, NC; ⁴Bucay Center for Dermatology and Aesthetics, San Antonio, TX; ⁵Skin & Aesthetic Surgery of Manhattan, Manhattan, NY; ⁶Houshmand Dermatology and Wellness, Dallas, TX; ⁷Chicago Cosmetic Surgery and Dermatology, Chicago, IL; ⁸Rebecca Fitzgerald MD Inc., Los Angeles, CA; ⁹Moradi M.D., Carlsbad, CA; ¹⁰Aesthetx, Campbell, CA; ¹¹Allergan Aesthetics, an AbbVie company, Irvine, CA; ¹²Image Dermatology, Montclair, NJ

Background: Most research on skin quality focuses on facial attributes, but there is growing interest to better understand which characteristics of skin quality on the body (ie, anywhere below the neck) may be of concern for patients.

Methods: A large online survey of aesthetically inclined adults in the US sought to understand aesthetic concerns including those related to body skin quality and how these may differ by race and ethnicity, gender, and age. Eligible respondents were adults aged 22–85 years who care about improving their appearance and are willing to go to a professional to do so (ie, aesthetically inclined). From a total of 31 body characteristics, 12 of which were deemed to be related to skin quality, respondents identified all characteristics they had and found bothersome; this provided frequency of concern. To assess how bothersome these characteristics were, Maximum Difference scaling was used; from a randomized set of five characteristics, participants were asked to select the most and least bothersome among the set, which produced a percentage indicating the proportion of time a particular characteristic was chosen as the most bothersome when shown in an average bundle. Top body skin quality concerns were those that were both most frequently indicated as an aesthetic concern and ranked most bothersome.

Results: A total of 3,974 adults completed the survey; 82.4 percent (n=3,273) self-identified as female, including transgender female, 17.5 percent (n=697) identified as male, including transgender male, and 0.1 percent (n=4) identified as non-binary. The top three concerns related to body skin quality among female respondents were cellulite on the thighs/legs, sagging skin, and tied for third place, cellulite on the buttocks, stretch marks, and uneven skin color or hyperpigmentation on the body. White, Middle Eastern, and Hispanic/Latina female respondents were more concerned with cellulite on the buttocks than stretch marks and uneven skin color or hyperpigmentation. Cellulite in the thighs/legs was the top concern across ethnic groups and generations. In addition, among Generation Z/Young Millennial (≤30 years) and Older Millennial (31–41 years) female respondents, stretch marks were a top concern, while sagging skin on the body was of greater concern among Baby Boomer+ (58–85 years) female respondents. The top three body skin quality concerns among male respondents were sagging skin, rough/uneven skin texture, and uneven skin color or hyperpigmentation. Sagging skin was consistently a top concern across all ethnicities. In addition, stretch marks tied with sagging skin as a top concern among Black male respondents while dry skin/lack of hydration and crepey skin were top concerns among White male respondents. Generational differences were present, with younger respondents (Gen Z/Young Millennial; ≤30 years) expressing more concern with crepey skin and rough/uneven skin texture than older respondents (Gen X–Baby Boomer+; 42–85 years).

Funding: Allergan Aesthetics, an AbbVie company funded this research and participated in the research design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Sarah J. Cross, PhD, of AbbVie Inc.

Conclusion: The findings from this large US survey provide important insight into the body skin quality concerns of aesthetically inclined adults and may help tailor patient consultations and treatments.

 

Aesthetic concerns regarding facial skin quality: Results from a large survey of aesthetically-inclined adults in the United States

Presenters: Sadeghpour M,¹ Sherber N,² Chiu A,³ Boyd C,⁴ George R,⁵ Hartman C,⁶ Hooper D,⁷ Keaney T,⁸ Munavalli G,⁹ Rahman Z,¹⁰ Woolery-Lloyd H,¹¹ Karic A,¹² Homola J,¹² Sondergaard B,¹² Burgess C¹³

Affiliations: ¹SkinMed Institute, Lone Tree, CO; ²Sherber + Rad, Washington, DC; ³The Derm Institute, North Redondo Beach, CA; ⁴BOYD, Birmingham, MI; ⁵Wilmington Dermatology Center, Wilmington, NC; ⁶Skin Wellness Dermatology, Birmingham, AL; ⁷Audubon Dermatology, New Orleans, LA; ⁸SkinDC, Arlington, VA; ⁹Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; ¹⁰Department of Dermatology, Stanford University School of Medicine, Stanford, CA; ¹¹Department of Dermatology and Cutaneous Surgery, University of Miami School of Medicine, Miami, FL; ¹²Allergan Aesthetics, an AbbVie company, Irvine, CA; ¹³Center for Dermatology and Dermatologic Surgery, Washington, DC

Background: Skin quality comprises multiple attributes such as hydration, roughness, uneven pigmentation, and elasticity.¹ However, there are minimal published data about both facial skin quality concerns across diverse patient populations and a lack of consensus on what aesthetic characteristics are considered skin quality related.

Methods: This large online survey of aesthetically inclined adults in the US sought to understand aesthetic concerns including those related to facial skin quality and how these may differ by race and ethnicity, gender, age, and other demographic variables. Eligible respondents were adults (22–85 years) who care about improving their appearance and are willing to go to a professional to do so (ie, aesthetically inclined). Respondents completed the online survey from February to April 2022. From 41 facial characteristics, 14 of which were identified as skin quality related, participants identified all characteristics they had and found bothersome; this provided frequency of concern. To assess how bothersome these characteristics were, Maximum Difference scaling was used; from a randomized set of five characteristics, participants were asked to select the most and least bothersome among the set, which produced a percentage indicating the proportion of time a characteristic was chosen as the most bothersome when shown in an average bundle. Top facial skin quality concerns were those that were both most frequently indicated as an aesthetic concern and most bothersome.

Results: Among 3,974 adults who completed the survey, 82.4 percent (n=3,273) self-identified as female, including transgender female; 17.5 percent (n=697) identified as male, including transgender male; and 0.1 percent (n=4) identified as non-binary. The top three facial skin quality concerns among female respondents were uneven skin color or hyperpigmentation, sagging skin, and dry or dull skin. Specifically, among Black, Asian, and Middle Eastern female respondents, acne scarring was also ranked as a top concern. Top concerns were similar across generations, except that as one ages, dry/dull skin and acne scarring became less prominent concerns and sagging skin became the top concern. Among male respondents, the top three facial skin quality concerns were sagging skin, acne scarring, and uneven skin color or hyperpigmentation; concerns were similar across ethnicity, except that Black and White male respondents in particular also ranked dry or dull skin as a top concern. Generational differences were also noted among male respondents; younger male respondents expressed high levels of concern over rough/uneven skin texture, whereas Generation X and Baby Boomer+ respondents combined (42–85 years) were most concerned with sagging skin.

Disclosures: CB is an investigator for Merz Aesthetics, Prollenium, Revance, and Allergan Aesthetics, an AbbVie company. AC is a consultant, advisory board member, and investigator for Merz and Allergan Aesthetics, an AbbVie company; and a consultant and advisory board member for Galderma, Evolus, and Sofwave. MS and NS are consultants and advisory board members for Allergan Aesthetics, an AbbVie company. CB and TK are advisory board members, investigators, speakers, and consultants for Allergan Aesthetics, an AbbVie company. HWL is a speaker for Ortho Dermatologics and Eli Lilly & Company; a speaker and consultant for Incyte and Loreal; investigator for Vyne, Eirion, Arcutis, Pfizer, and Galderma; an investigator and consultant for Allergan Aesthetics, an AbbVie company; a consultant for Johnson & Johnson, Bausch and Laumb, DermTech, and LivDerm. RG is an investigator and consultant for Galderma and Allergan Aesthetics, an AbbVie company. CH, GM and ZR are advisory board members for Allergan Aesthetics, an AbbVie company. JH, AK, and BS are employees of AbbVie Inc and may own AbbVie stock.

Funding: Allergan Aesthetics, an AbbVie company funded this research and participated in the research design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Sarah J. Cross, PhD of AbbVie Inc.

Conclusion: The findings from this large US survey provide important insight into the facial skin quality concerns of aesthetically inclined adults and may help in tailoring patient consultations and treatments. 

References:

1. Humphrey et al. 2021. Defining Skin Quality: Clinical Relevance, Terminology, and Assessment Dermatol Surg. 1;47(7):974–981.

Importance of posttreatment follow-up with patients in aesthetic practice

Presenters: Garcia JK,¹ Bennett ME,² Musumeci M,³ Hogue SL,⁴ Patel VD¹ 

Affiliations: ¹AbbVie, Irvine, CA, USA; ²Clarity Consulting, Raleigh, NC, USA; ³AbbVie, Rome, Italy; ⁴AESARA, Chapel Hill, NC, USA

Background: In aesthetic medicine, a patient-centered approach to prioritize their expectations, needs, and outcomes is important. Patients who do not achieve their desired outcomes may discuss their treatment experience with friends, family, and social networks instead of their healthcare provider (HCP). However, limited research has been conducted to date on this topic.

Objective: This study investigated the specific actions exhibited by patients following cosmetic neurotoxin treatment.

Methods: Adults residing in the United States, the United Kingdom, Canada, or Brazil who had received at least four cosmetic neurotoxin treatments ever, including at least one in the previous 12 months, were selected from online panels to complete a 15-minute online questionnaire in their local language. Patients were asked to recall their most and least positive experiences with cosmetic neurotoxin treatment and to report their overall level of satisfaction with the process and outcome of treatment (eg, ease of working with office staff, achievement of a natural look) as well as the actions they engaged in after treatment for each type of experience (eg, returning to the same practice, asking for the same brand at the next visit, posting on social media, talking to friends/family). Results are presented descriptively.

Results: A total of 1,612 qualified patients (United States, n=407; Canada, n=403; United Kingdom, n=402; Brazil, n=400) completed the questionnaire from September 26 through December 30, 2022. The sample was 61 percent female and mean age was 38 years; 58 percent had received five or more neurotoxin cosmetic injections. After having a positive experience, most patients (81%) engaged in actions directed toward the HCP (eg, scheduled another treatment or posted a review on the HCP’s website) and others (eg, talked to friends or family about the experience or posted a review on social media). After their least positive experience, only a small percentage (22%) of patients communicated directly with their HCP. However, more patients took other actions, such as talking to friends and family about their experience (33%), posting reviews on social media or other websites (32%), or seeking corrective treatment from another HCP (33%). Of patients who talked to friends and family or posted a review after their least positive experience, 52 percent discouraged others from using the HCP who performed their procedure and 27 percent discouraged others from seeking cosmetic neurotoxin injections. In addition, 30 percent of patients planned to switch to a new HCP and 13 percent decided to stop receiving cosmetic neurotoxin treatments altogether.

Conclusion: The results of this global survey underscore the importance of HCPs providing consistent follow-up with patients after treatment to understand their perspectives on outcomes and discuss options. Only a small proportion of patients proactively communicated with their HCP after their least positive experience; however, more patients chose to inform others of their unfavorable experience. These findings suggest that follow-up with patients to address concerns may help improve patient satisfaction and alleviate actions that arise following an unfavorable experience.

Disclosures: JKG, MM, and VP are full-time employees of AbbVie. MEB is the principal strategist at Clarity Consulting and is a consultant for AbbVie. SLH is a full-time employee of AESARA and a consultant for AbbVie.

Funding: Allergan Aesthetics, an AbbVie Company, funded this trial and participated in the trial design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Yvette Edmonds, PhD, of Peloton Advantage, LLC (an OPEN Health company).

 

The burden and psychosocial impact of platysma prominence

Presenters: Yoelin S,¹ Bank D,² Fagien S,³ Dayan S,⁴ Ogilvie P,⁵ Tong W,⁶ Shimoga S⁶

Affiliations: ¹Steven Yoelin, MD, Medical Associates Inc, Newport Beach, CA, USA; ²The Center for Dermatology, Cosmetic & Laser Surgery, Mt. Kisco, NY, USA; ³Steven Fagien, MD, Aesthetic Plastic Surgery, Boca Raton, FL, USA; ⁴DeNova Research, Chicago, IL, USA; ⁵Skin Concept, Munich, Germany; ⁶AbbVie, Irvine, CA, USA

Background: Platysma prominence (PP) presents with contraction of the platysma muscle, causing an undesirable aesthetic effect due to blunting of the jawline and the appearance of vertical neck bands. PP can be exacerbated with aging and may have negative effects on quality of life and psychological and emotional well-being, but literature on this is limited. 

Objective: The objective of this study was to characterize the burden of PP using in-depth interviews of previously treated patients, along with baseline data from two pivotal Phase 3 studies evaluating the safety and efficacy of onabotulinumtoxinA for treatment of moderate to severe PP.

Methods: In the qualitative study, demographic information was collected and PP severity was assessed using the validated Clinician Allergan Platysma Prominence Scale (C-APPS; 5-grade scale ranging from 1 [minimal] to 5 [extreme]). Interviews lasting approximately 60 minutes were conducted by trained interviewers. Participants were asked open-ended questions designed to encourage spontaneous responses exploring the psychosocial impacts of PP from a patient perspective, as well as their reasons for seeking PP treatment and treatment expectations. Participants also rated the bothersomeness of each psychosocial impact before treatment (11-grade scale ranging from 0 [not bothersome at all] to 10 [extremely bothersome]). Pretreatment PP burden among participants in the two double-blind, placebo-controlled Phase 3 clinical trials (NCT04949399 and NCT04994535) was assessed using the validated Bother Assessment Scale–Platysma Prominence (BAS-PP) and Appearance of Neck and Lower Face Questionnaire (ANLFQ): Impacts, a measure developed to assess patient perspectives on the psychosocial burden of PP. ANLFQ: Impacts includes seven items to measure appearance and emotional and social factors that impose PP-related psychosocial burden; each item ranges from 1 (never) to 5 (all of the time) (summary score range, 7−35; higher scores indicate greater negative impact). Additional details of the clinical studies are described elsewhere.

Results: The majority of the qualitative study participants (N=24; 88% female; 88% White; mean age, 50 years) had Moderate (67%) or Severe (21%) PP on the C-APPS. A majority of participants (67%) were dissatisfied with the appearance of their lower face and neck before treatment, reporting a noticeable effect of PP on the appearance of their neck (96%) or lower face/jawline (67%). Top reasons for seeking treatment were to reduce noticeability of the neck bands (46%) and to reduce signs of aging (33%). The most common treatment expectations were to reduce (42%) or eliminate (17%) noticeable neck bands. By design, the two clinical studies’ inclusion criteria required that participants be at least Somewhat bothered by the appearance of their vertical neck bands (study 1: 97.6%; study 2: 98.6%) and jawline (97.1%; 94.6%, respectively), reflecting the qualitative perspectives on the reasons patients seek PP treatment and their dissatisfaction with the appearance of their neck and lower face. In the qualitative interviews, participants identified 27 psychosocial impacts of PP across three categories: appearance related (n=11 impacts), emotional (n=13), and social (n=3). Looking older than desired was the most frequently reported appearance-related impact (96%) and the most frequently reported impact overall, while the most common emotional and social impacts were feeling less attractive (71%) and receiving unwanted attention (21%), respectively. Mean bothersomeness ratings ranged from 5.0 to 10.0 for appearance-related and emotional impacts and from 1.8 to 8.0 for social impacts. In the clinical studies, the mean baseline ANLFQ: Impacts summary scores were 24.2 and 24.5, indicating the inclusion of those with higher psychosocial burden, which aligns with the bothersomeness described by the qualitative study participants.

Conclusion: Meaningful incorporation of the patient’s voice to understand burden of condition and treatment benefit is a vital part of the drug development and evaluation process. Participants in qualitative interviews reported psychosocial impacts of PP, such as feeling self-conscious and a lack of confidence. These results are consistent with pretreatment PP impacts reported by participants in the Phase 3 clinical studies and highlight the substantial psychosocial impact of PP on individuals’ daily lives.

Disclosures: DB, SD, SF, PO, and SY are investigators for Allergan Aesthetics, an AbbVie Company. WT and SS are investigators for Allergan Aesthetics, an AbbVie Company.

Funding: Allergan Aesthetics, an AbbVie Company, funded this trial and participated in the trial design, research, analysis, data collection, interpretation of data, and the review and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Illyce Nuñez, PhD, of Peloton Advantage, LLC (an OPEN Health company).

 

 ATOPIC DERMATITIS

A phase 2b, randomized, double-blind, placebo-controlled, multi-center, global study to evaluate the efficacy and safety of ANB032 in the treatment of subjects with moderate to severe atopic dermatitis 

Presenters: Ehst B,¹ Lizzul P,² Luu K,² Rigby M,² Raina P,² Sibley C,² Randazzo B² 

Affiliations: ¹Oregon Medical Research Center, Portland, OR, USA; ²AnaptysBio, Inc., San Diego, CA, USA 

Background: BTLA is a key checkpoint receptor that is expressed across a range of activated immune cells, such as T-cells, B-cells and dendritic cells (DC), that drive inflammatory diseases. ANB032, a BTLA agonist antibody, has the potential to modulate all phases of the pathogenic inflammatory response with broad applicability to inflammatory diseases where the BTLA pathway is dysregulated, such as in dermatology, rheumatology, gastroenterology, etc. 

Objective: In preclinical studies, ANB032 inhibited activated T cell proliferation, reduced inflammatory cytokine secretion (Th1, Th2, Th17, and Th22) and modulated DC function, including inducing T regs. In a Phase 1 first-in-human healthy volunteer study, ANB032 was well-tolerated, had a favorable PK profile, demonstrated robust target engagement and a partial reduction in BTLA expression, consistent with observations in animal models of dermatitis and inflammation. The robust pre-clinical data and Phase 1 trial results, support the rationale for advancing the clinical development of ANB032 in a Phase 2 study in atopic dermatitis (AD), a systemic and heterogeneous inflammatory disease driven by the involvement of broad T-cell lineages including Th1, Th2, Th17, and Th22 cells, along with DCs. 

Methods: This global Phase 2b study is a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial to evaluate the safety, tolerability, and efficacy of ANB032 in subjects with moderate-to-severe AD. Eligible subjects will be 18 to 65 years of age and have a clinical diagnosis of moderate-to- severe AD affecting at least 10 percent of their total body surface area, an Eczema Area and Severity Index (EASI) score > 16, and a validated Investigator Global Assessment (IGA) for Atopic Dermatitis score > 3. Importantly, subjects who are either dupilumab/IL-13 blocker-naïve or -experienced are eligible for enrolment. The treatment period is 14 weeks (weeks) with an additional 12-weeks of follow up. Subjects will be randomized in a 1:1:1:1: ratio in four equal treatment groups, evaluating three SC doses and schedules of ANB032 and placebo. Dosing schedules are every two weeks or every four weeks. The primary endpoint is mean change from baseline in EASI at Week 14. Secondary endpoints include EASI75, IGA 0/1, PNRS, DLQI, SCORAD50, and safety. Tape strips and/or tissue biopsies will be collected to assess biomarkers, such as Th1/Th2/Th17, as exploratory endpoints

Results: The study initiated in May 2023. Top-line data are expected by year end 2024.

Conclusion: Current treatment options in AD do not target all of the diverse immune cells and cytokines that contribute to the pathogenesis of this disease. This Phase 2b study of ANB032 will add to the evolving treatment landscape of AD and further the understanding of the biology of this heterogenous disease (NCT NCT05935085).

Disclosures: PL, KL, MR, PR, CS, BR are employees of Anaptys.

Funding: This research was sponsored by Anaptys.

 

 ENERGY-BASED TREATMENTS

Real-world experience using a multi-modality system that combines intense pulsed light, laser hair removal, high-intensity focused ultrasound, fractional radiofrequency microneedling, and thermal radiofrequency for skin rejuvenation treatment

Presenters: Gold M,¹ Andriessen A,² Biesman B,³ Cohen JL,⁴ Goldberg D,⁵ Schlesinger T,⁶ Taher Z⁷ 

Affiliations: ¹Gold Skin Care Center, Nashville, Tennessee, Clinical Assistant Professor, Vanderbilt University School of Nursing, Nashville, Tennessee; ²Radboud UMC, Nijmegen and Andriessen Consultants, Malden, The Netherlands; ³Nashville, Tennessee; ⁴Denver, Colorado; ⁵Skin Laser & Surgery Specialists, Schweiger Dermatology Group, Icahn School of Medicine at Mt. Sinai, New York, New York; ⁶Dermatology and Laser Center of Charleston, Clinical Research Center of the Carolinas, Clinical Instructor, University at Buffalo Department of Dermatology, Medical University of South Carolina College of Medicine Edward Via College of Osteopathic Medicine, Charleston, South Carolina; ⁷Edmonton, Alberta

Background: Medical aesthetic procedures for facial antiaging with laser and energy-based devices (EBDs) are rapidly increasing.

Objective: The poster highlights real-life experience using a multi-modality system with various handpieces that combine intense pulsed light (IPL), laser hair removal (808), high intensity focused ultrasound (HIFU), fractional radiofrequency microneedling (FRFM) and thermal radiofrequency (RF) for rejuvenation treatment.

Methods: Laser and FRFM treatments may improve skin conditions by inducing cutaneous changes that remodel the skin matrix. Six physicians who treat patients for skin rejuvenation reported on clinical cases from their practice using a multi-modality system with various handpieces. During the meeting, the advisors discussed 15 cases and agreed to select seven patients with different ages and skin phototypes¹ receiving various treatments for photodamage of the face, neck, and decollete. 

Results: The advisors discussed why they selected the case, previous treatment, type of treatment, results, and clinical pearls. Case 1: The 56-year-old female with skin phototype III had facial age-related photodamage. She received three monthly IPL and RFM sessions to improve skin tone and texture. At Week 12, her skin tone, texture, fine lines, and wrinkles had markedly improved. Case 2: The 58-year-old female with skin phototype III and facial photodamage received IPL and three monthly FRFM treatments. At Week 12, she reported a more healthy-looking skin tone and texture. Case 3: The 60+ female with skin phototype I and photodamage of her neck and decollete received two treatments with RF, markedly improving her skin tone and texture by Week 12. Case 4: A 55-year-old female with skin phototype III and photodamage of her face, neck, and decollete received two treatments with 640 Filter Toning and 560, which improved her skin tone and texture by Week 12. Case 5: The 26-year-old male with skin phototype IV received three monthly FRFM treatments to his face. At Week 12, he reported a more even, healthy-looking skin tone and texture. Case 6: The 59-year-old female with skin phototype II had photodamage of her face and neck. She requested treatment with HIFU to focus on her lower face, lips, and neck, which markedly improved her skin tone and texture by Week 12. Case 7: A 39-year-old female with skin phototype II and laxity of skin and overall texture concerns received three monthly IPL for redness and RFM sessions to improve skin tightening and texture. At Week 12, her facial erythema and skin texture had improved significantly. 

Conclusion: Sharing best practices in medical aesthetics using combination treatments on a single multi-modality energy-based device such as laser and MRF for facial, neck, and chest skin may support healthcare providers treating patients for skin rejuvenation to improve clinical outcomes.

Funding: This article was supported by an unrestricted educational grant from LUVO. The authors received an educational grant, and the multi-modality system (Darwin) that combines IPL, 808, HIFU, RFM, and RF from LUVO Medical, Canada, was made available for conducting the cases.

References: 

1. Eilers S et al. Accuracy of self-report in assessing Fitzpatrick skin phototypes I through VI. JAMA Dermatol. 2013;149(11):1289–1294.

Novel post-procedure topical treatment enhances patient comfort post-hybrid fractional laser

Presenters: Young MB,¹ Namnoum J,² Burns AJ,³ Blackwell E,^2,4 Alcalan K,³ Kononov T,¹ Zahr AS¹

Affiliations: ¹Revision Skincare, Irving, TX, USA; ²AYA Medical Spa, Atlanta, GA, USA; ³Resurrect MD, Dallas, TX, USA; ⁴EnlightenU, Atlanta, GA, USA

Background: Energy-based skin rejuvenation devices are effective, however post-procedure discomfort can limit patients from completing a treatment series. A skincare treatment that improves tolerability and promotes recovery post-procedure is needed.

Objective: To develop a post-procedure cream (PPC) that can immediately be used by patients after receiving an energy-based treatment to ameliorate discomfort and promote healing for enhanced recovery and increased likelihood patients will complete a recommended treatment series. A 14-day multi-center, randomized, double-blinded, split-face, controlled case study was conducted to demonstrate improved patient downtime following a hybrid fractional laser (HFL) treatment in healthy women 35–65 years old with Fitzpatrick Skin Types I-III and moderate-severe facial photodamage.

Methods: A breathable, semi-occlusive post-procedure cream (PPC) was formulated with botanical actives to directly stimulate nervous system/skin communication (neurocosmetic), microbiome technology, and hydrators. Neither topical anesthetics nor alcohol were added to the formulation. Twenty subjects (10 per site) were recruited for one HLF treatment (350/20/20/18). One-hour numbing was allowed pre-procedure. Based on split-face randomization, subjects applied the PPC and a comparator moisturizer (CM) immediately post-procedure and for seven days post-procedure (morning/afternoon/evening). Tolerability assessments, self-assessment questionnaires, and photographic evaluations were completed over seven days. Subjects used a basic skincare regimen throughout the study.

Results: Sixteen subjects (8 per site) completed the study. When used three times daily for seven days, both the PPC and CM were tolerable. Twenty-four hours post-procedure, 88% (PPC) versus 62% (CM) of subjects favorably agreed “the feeling of warmth/heat is decreased;” additionally, 75% (PPC) vs. 44% (CM) of subjects favorably agreed “I feel less irritation.” Comparing the PPC to the CM, a current standard of care, photographic analysis of skin redness and vascularity showed that a majority of subjects improved across all timepoints indicating the PPC did not impede the treatment response. 

Conclusion: The PPC demonstrated greater soothing benefits over seven days compared to a CM. The PPC fills an unmet need by improving post-procedure discomfort and enhancing recovery to increase patient treatment plan adherence. 

Funding: Funding for this study was provided by Revision Skincare®.

 

Post-procedure cream with unique neurotopical technology improves patient experience and recovery following fractional ablative CO₂ laser treatment

Presenters: Young MB,¹ Kononov T,¹ Zahr AS,¹ Weir N²

Affiliations: ¹Revision Skincare, Irving, TX, USA; ²The Dermatology Group, Blue Ash, OH, USA

Background: Thermal lasers are an established method to rejuvenate skin, however multiple treatments are typically needed to achieve optimal results. A topical post-procedure product that can diminish discomfort and enhance recovery following thermal laser procedures could improve patient compliance with completing the recommended treatment series. A breathable, semi-occlusive post-procedure cream (PPC) containing unique neurotopical technology, microbiome technology, as well as lipophilic and hydrophilic hydrators was developed. Composed of a blend of botanical actives, the neurotopical technology was included to comfort skin post-procedure by directly targeting communication between the skin and nervous system. Uniquely, the PPC does not contain topical anesthetics or alcohol. The PPC was initially investigated in a 14-day multi-center, randomized, double-blinded, split-face, controlled clinical case study to evaluate the efficacy and tolerability of the PPC to an over-the-counter Comparator Moisturizer (CM) when paired with a hybrid fractional laser treatment. Results showed the PPC was effective and safe when used post-procedure, with subjects indicating greater preference for the PPC over the CM on multiple parameters such as decreased feeling of warmth/heat and irritation 24 hours post-procedure. Additionally, photographic image analysis showed decreased skin erythema and vascularity suggesting PPC supports dermal healing.

Objective: The first objective was to evaluate the efficacy and safety of the PPC after fractional ablative CO₂ laser (FACL) with the SmartXide Tetra CO₂ laser (DEKA, Calenzano, Italy). The second objective was to compare the treatment response to a comparator anhydrous formulation (CAF). 

Methods: This was a 28-day single-center, randomized, double-blinded, split-face, controlled case study involving healthy female subjects 35–65 years old with Fitzpatrick Skin Types I–III and with moderate-severe photodamage. Twenty-three subjects were recruited for one FACL treatment performed by the principal investigator, a board-certified dermatologist. Two weeks prior to the procedure, subjects completed a washout using a gentle foaming cleanser and basic moisturizer twice daily (morning and evening) and a basic mineral sunscreen SPF 50 in the morning with reapplications as needed throughout the day. On procedure day, all subjects received one-hour numbing under occlusion pre-procedure. The FACL treatment was performed using power 20W, spacing 500µm (13% density), dwell time 1,200µs pulse duration, and spray mode on. A medical assistant ensured proper smoke ventilation, and the Cryo 7 by Zimmer (Irvine, CA, USA) was used to provide tissue cooling. Based on split-face randomization, subjects applied the PPC and CAF immediately post-procedure and for 14 days post-procedure (morning/afternoon/evening). For the first three days post-procedure, a basic ointment was additionally applied to the comparator side since the CAF is not considered to have sufficient moisturizing benefits. From procedure day to the final visit on Day 14 post-procedure, subjects used the gentle foaming cleanser three times daily (morning/afternoon/evening) before product application. Starting on Day 3 post-procedure, the basic moisturizer and sunscreen were incorporated back into the skincare regimen. Assessments were completed on procedure day and Days 1, 3, 5, 7, and 14 post-procedure. The principal investigator clinically graded tolerability parameters, and subjects completed tolerability and product questionnaire self-evaluations. Standardized photography was also performed to capture treatment response over the course of the study. Twenty-two healthy female subjects with an average age of 51 years and Fitzpatrick Skin Types I-III completed the case study. 

Results: The PPC was found to be effective and tolerable post-FACL treatment. Self-assessment questionnaire results for the PPC side showed that immediately post-procedure, 86 percent of subjects favorably agreed that “The product was gentle on my skin.” Twenty-four hours post-procedure, 82 percent of subjects favorably agreed with the statement, “The product soothed my skin (from burning sensation)” and 91 percent favorably agreed that, “The product calmed my skin.” Fourteen days post-procedure, 86 percent of subjects favorably agreed with the statements, “The product reduced irritation on the skin post-procedure,” “The product provided relief to dry, damaged skin,” and, “The product helps to protect my skin post-procedure.”

Conclusion: Overall, the PPC provided the same or greater benefits in comforting the skin and improving recovery over 14 days post-FACL treatment versus the CAF. The PPC is a single product that moisturizes, soothes, and enhances skin recovery post-procedure, helping to improve the post-procedure patient experience.

Funding: Funding for this study was provided by Revision Skincare®.

References:

1. Doherty SD, Doherty CB, Markus JS, et al. A paradigm for facial skin rejuvenation. Facial Plast Surg. 2009 Nov;25(4):245–251. 
2. Andrei C, Zanfirescu A, Nițulescu GM, et al. Natural Active Ingredients and TRPV1 Modulation: Focus on Key Chemical Moieties Involved in Ligand-Target Interaction. Plants (Basel). 2023;12(2):339. 
3. Hettwer S, Bänziger S, Suter B, Obermayer B. Grifolin derivatives from Albatrellus ovinus as TRPV1 receptor blockers for cosmetic applications. Int J Cosmet Sci. 2017;39(4):379–385. 
4. Atkins D, Frodel J. Skin rejuvenation in facial surgery. Facial Plast Surg. 2006 May;22(2):129–139.
5. Cohen JL, Ross EV. Combined fractional ablative and nonablative laser resurfacing treatment: a split-face comparative study. J Drugs Dermatol. 2013 Feb;12(2):175–178. 
6. Alexiades-Armenakas, MR, et. Al. The spectrum of laser skin resurfacing: Nonablative, fractional, ablative laser resurfacing. J Am Acad Dermatol. 2008; 58(5):719–737.
7. Nelson AM, Ortiz AE. Effects of anhydrous gel with TriHex peptides on healing after hybrid laser resurfacing. J Cosmet Dermatol. 2020 Apr;19(4):925–929.

Synchronous ultrasound parallel beam technology for acne scars appearance improvement

Presenters: Amir R,¹ Geronemus R,² Kauvar A,³ Chapas A,⁴ Goldberg D⁵

Affiliations: ¹Sofwave Medical Ltd, Yokneam, Israel; ²Laser & skin Surgery center of New York, New York, NY, USA; ³New York Laser & skin Care, New York, NY, USA; ⁴Union Square Laser Dermatology, New York, NY, USA; ⁵Schweiger Dermatology, Hackensack, NJ, USA 

Background: Synchronous Ultrasound Parallel Beam Technology safely coagulates the mid-dermis to maximize neocollagenesis and neoelastogenesis, while providing feedback-controlled energy deposition and skin cooling. The technology utilizes multiple high frequency, low divergent ultrasound beams that simultaneously deliver a high-density thermal dose to the mid-dermis at 1.5mm depth, increasing tissue temperatures to 60–70°C and inducing tissue remodeling. Clinical study evaluated the efficacy and safety of this technology for improving the appearance of Acne scars.

Objective: This clinical study evaluated the efficacy and safety of this technology for improving the appearance of acne scars.

Methods: Multi-center, prospective, self-control clinical study was conducted in four US sites. Sixty-seven (N=67) subjects underwent three treatments (1–3 weeks apart) and were followed three months post last treatment. Three independent masked reviewers, who were not involved in the study, were asked to identify the post-treatment images, which were presented to them after randomization of the pre and post treatment images and to rank the acne scars severity (using 4-point scale: 0=absent, 1=mild, 2=moderate. 3=severe). Anticipated tissue responses and safety aspects were recorded throughout the study. Subjects ranked their discomfort during treatments.

Results: Following three treatment sessions, 97 percent of treated subjects showed improvement in acne scars appearance, as assessed (by the correct identification of the post treatment photograph) by at least 2 of 3 blinded evaluators. The mean improvement level of 1.05±0.53 units based on the acne scar severity scale, reflected an improvement of 46 percent of the baseline acne scars severity grading. Furthermore, subjects were highly satisfied and 88 percent of the subjects reported on improvement in their acne scars appearance. There were no device related adverse events. Anticipated tissue responses were mostly erythema and edema, which resolved spontaneously after treatment. Most of the subjects reported none to moderate levels of pain during treatment and no discomfort afterward.

Conclusion: Synchronous ultrasound parallel beams treatment was demonstrated to safely improve acne scars appearance.

Disclosures: RA is an employee and shareholder of Sofwave Medical Ltd. RG, AK, AC and DG served as study investigators.

 

Synchronous ultrasound parallel beam technology for cellulite appearance improvement

Presenters: Amir R,¹ Munavalli G,² Kilmer S,³ Chapas A,⁴ Geronemus R⁵

Affiliations: ¹Sofwave Medical Ltd, Yokneam, Israel; ²Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC, USA; ³Laser and skin surgery center of Northern California, Sacramento, CA, USA; ⁴Union Square Laser Dermatology, New York, NY, USA; ⁵Laser & skin Surgery Center of New York, NY, USA

Background: A novel ultrasound device can safely target the mid-dermis to maximize neocollagenesis and neoelastogenesis, while incorporating feedback-controlled skin cooling and energy deposition. This device utilizes synchronous ultrasound parallel beams to deliver seven beams of thermal energy at once to the mid-dermis at 0.5–2.0mm, increasing tissue temperatures to 60–70°C.

Objective: This study assessed the efficacy, safety and tolerability of this device to improve the cellulite appearance.

Methods: A total of 68 female participants from four US clinical sites were enrolled at a prospective clinical study. Subjects received two treatments on the upper thigh/buttock area and were followed up at three-month post-treatments. Following each treatment, subjects ranked the pain using 10-point scale. Safety aspects were recorded along the study course. Two independent masked reviewers, identified the three-month post-treatment images, which were presented to them randomly with the pre-treatment images and assess the cellulite and lax skin severity using the Cellulite Severity Scale (CSS; 6-point scale: 0=no cellulite and 5=severe cellulite) and the Skin Laxity Scale (LS; 4-point scale: 0=absence of laxity, flaccidity, or sagging skin and 3=severe draped appearance).

Results: Two blinded reviewers were in agreement in identifying the pre- and post-treatment photographs correctly for 89 percent of the treated areas and claimed for improvement in both aspects of cellulite appearance and skin laxity. The cellulite appearance was improved on average with 1.61 CSS units (95%CI 1.39, 1.82) which represents 57 percent from the baseline CSS condition. Skin laxity was improved on average of 0.70 LS units (95% CI 0.58, 0.82) which represents 44% improvement from the baseline LS condition. Most of the subjects reported on none to mild discomfort during treatment (scores 0-5; mean 4.55). No related adverse events were recorded, and anticipated responses were mostly limited to erythema and edema (all resolved spontaneously).

Conclusion: This novel ultrasound device was demonstrated to safely provide cellulite appearance improvement.

Disclosures: RA is an employee and shareholder of Sofwave Medical Ltd. GM, SK, CA and RG served as study investigators. 

 

PSORIASIS

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in plaque psoriasis: 3-year psoriasis area and severity index (PASI) outcomes in the long-term extension of the phase 3 POETYK PSO-1 and PSO-2 trials

Presenters: Stein Gold L,¹ Banerjee S,² Colombo MJ,² Kisa RM,² Berger V,² Hoyt K,² Soung J,³ Torres T,⁴ Bhatia N,⁵ Glick BP,⁶ Kaufmann M⁷

Affiliations: ¹Division of Dermatology, Henry Ford Health System, West Bloomfield, MI, USA; ²Bristol Myers Squibb, Princeton, NJ, USA; ³Southern California Dermatology, Santa Ana, CA, USA; ⁴Department of Dermatology, Centro Hospitalar Universitário do Porto and University of Porto, Porto, Portugal; ⁵Therapeutics Clinical Research, San Diego, CA, USA; ⁶Glick Skin Institute, Wellington, FL, USA; ⁷Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA

Background: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the US, EU, and other countries for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was efficacious and well tolerated in the global, 52-week, Phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials.

Methods: Patients were randomized 1:2:1 to oral placebo, deucravacitinib 6mg once daily, or apremilast 30mg twice daily. At Week 52, patients could enroll in the POETYK long-term extension (NCT04036435) trial and receive open-label deucravacitinib. Efficacy was evaluated in patients (n=513) who received continuous deucravacitinib from Day 1 of the parent trials for up to three years (Week 148), as of the data cutoff (June 15, 2022). Outcomes included mean change from baseline PASI, analyzed using modified baseline observation carried forward, and proportions of patients achieving treat-to-target absolute PASI thresholds.

Results: From a mean (SD) baseline PASI score of 21.1 (7.9), improvements were observed beginning at Week 1 (mean change, −3.2 [4.9]) through Week 16 (−15.7 [9.0]), further improved through Week 52 (−17.6 [8.0]), and maintained through Week 148 (−16.4 [8.7]). Proportions of patients achieving 75%-80% reduction from baseline in PASI (75<80), 80<85, 85<90, 90<95, and 95<100, treat-to-target absolute PASI thresholds of ≤1, ≤2, ≤3, ≤4, and ≤5, and absolute PASI of >1 to ≤3 and >3 to ≤5 were increased/maintained from Week 16 through Week 52 and subsequently through Week 148.

Conclusion: Efficacy outcomes in PASI scores and at treat-to-target thresholds were clinically meaningful through three years of continuous deucravacitinib treatment.

Disclosures: LSG is a consultant, advisory board member, and/or speaker at AbbVie, Amgen, Arcutis, Aslan, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB. SB, MJC, RMK, and VB are employees and shareholders at Bristol Myers Squibb. KH is a consultant at Bristol Myers Squibb via Syneos Health. JS is a consultant, advisory board member, investigator, and/or speaker at AbbVie, Amgen, Arcutis, Aslan, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Incyte, Kobio Labs, Janssen, Leo Pharma, Novartis, Ortho, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB. TT is an investigator, consultant, and/or speaker at AbbVie, Amgen, Almirall, Arena, BIOCAD, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Fresenius-Kabi, Janssen, Leo Pharma, Merck Sharpe Dohme, Mylan, Novartis, Pfizer, Samsung-Bioepis, Sandoz, Sanofi Genzyme, and UCB. NB is an advisor and consultant investigator at AbbVie, Almirall, Arcutis, Arena, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Incyte, ISDIN, Johnson & Johnson, Leo Pharma, Lilly, Ortho, Pfizer, Regeneron, Sanofi, Stemline, and Sun Pharma and an Investigator at Arcutis, Biofrontera, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Galderma, Leo Pharma, Lilly, and Ortho. BPG is an advisory board member, consultant, speaker, and investigator (with honoraria) and/or grants at AbbVie, Amgen, Almirall, Arcutis, AstraZeneca, Bausch Health/Valeant, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Cara Therapeutics, ChemoCentryx, CorEvitas Atopic Dermatitis Registry, CorEvitas Psoriasis Registry, Dermavant, Dermira, Eli Lilly, EPI/Novan Pharmaceuticals, Galderma, Incyte, Janssen, Leo Pharma, Nimbus Lakshmi, Novartis, Ortho Dermatologics, Pfizer, PROSE Registry, Regeneron, Sanofi, Sun Pharma, and UCB and a shareholder at Top MD. MDK is an advisory board at Rise Healthcare Tech and a  stockholder at Modernizing Medicine, MoleSafe, and Rise Healthcare Tech.

Funding: This study was funded by Bristol Myers Squibb. Writing and editorial assistance was provided by Jieming Fang, MD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb.

 

Efficacy of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in scalp psoriasis by baseline Psoriasis Area and Severity Index and baseline Body Surface Area: A subanalysis of the phase 3 clinical trial data 

Presenters: Blauvelt A,¹ Sofen H,² Lambert J,³ Merola JF,⁴ Lebwohl M,⁵ Hoyt K,⁶ Kisa RM,⁶ Banerjee S,⁶ Scharnitz T,⁶ Crowley J⁷

Affiliations: ¹Oregon Medical Research Center, Portland, OR, USA; ²Division of Dermatology, University of California Los Angeles and Dermatology Research Associates, Los Angeles, CA, USA; ³Faculty of Medicine and Health Sciences, Department of Head and Skin, Ghent University, Ghent, Belgium; ⁴Department of Dermatology, UT Southwestern Medical Center, Dallas, TX, USA; ⁵Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York NY, USA; ⁶Bristol Myers Squibb, Princeton, NJ, USA; ⁷Bakersfield Dermatology, Bakersfield, CA, USA

Background: Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, is approved in the US, EU, and other countries for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was effective and well tolerated in the global, 52-week, Phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials. 

Objective: Here, efficacy of deucravacitinib in scalp psoriasis was evaluated by baseline severity of psoriasis in the trial patients with scalp involvement.

Methods: Patients with moderate to severe scalp involvement (scalp-specific Physician Global Assessment [ss-PGA] score ≥3) at baseline were included in this analysis. Efficacy outcomes (ss-PGA score of 0 or 1 [ss-PGA 0/1] and ≥90% reduction from baseline in Psoriasis Scalp Severity Index [PSSI 90]) were reported through Week 24 (pooled PSO-1/PSO-2, before PSO-2 rerandomization, n=514) and Week 52 (PSO-1, continuous deucravacitinib, n=192). Outcomes were stratified by baseline PASI score 12-<15 (low) or ≥15 (high) and baseline BSA involvement 10%-≤15% (low) or >15% (high).

Results: ss-PGA 0/1 response rates were high and slightly greater in the high versus low PASI subgroup at Week 24 (65.8% and 58.3%, respectively) and Week 52 (73.5% and 60.0%). Similarly, PSSI 90 response rates were high and also somewhat greater in the high versus low PASI subgroup at Week 24 (55.3% and 45.8%) and Week 52 (66.0% and 53.3%). Across the two baseline BSA subgroups, ss-PGA 0/1 and PSSI 90 response rates were comparable at Weeks 24 and 52.

Conclusion: Deucravacitinib was effective in patients with scalp involvement in psoriasis regardless of overall baseline disease severity.

Disclosures: AB is a speaker at AbbVie, Bristol Myers Squibb, Lilly, Pfizer, Regeneron, and Sanofi; a scientific advisor at AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Escient, Evelo Biosciences, Evommune, Forte Biosciences, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, Leo Pharma, Lilly, Lipidio, Merck, Monte Rosa Therapeutics, Nektar, Novartis, Overtone Therapeutics, Paragon, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB, Union, Ventyx Biosciences, Vibliome, and Xencor, and a clinical study investigator at AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Evelo Biosciences, Evommune, Galderma, Incyte, Janssen, Leo Pharma, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB, and Ventyx Biosciences. HS is a clinical investigator at AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Leo Pharma, Lilly, Novartis, andSun Pharma. JL received unrestricted grants from AbbVie, Almirall, Amgen/Celgene, Janssen-Cilag, Leo Pharma, Lilly, Novartis, and UCB, and is a speaker at AbbVie, Almirall, Bristol Myers Squibb, Janssen-Cilag, Pfizer, and UCB. JL is consultant at AbbVie, Amgen/Celgene, Bristol Myers Squibb, Janssen-Cilag, Leo Pharma, Lilly, Novartis, and UCB. JFM is a consultant and/or investigator at AbbVie, Amgen, Biogen, Bristol Myers Squibb, Dermavant, Janssen, Leo Pharma, Lilly, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. ML received research funds on behalf of Mount Sinai: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Incyte, Janssen, Lilly, Ortho Dermatologics, Regeneron, and UCB. ML is a consultant at Almirall, AltruBio, AnaptysBio, Arcutis, Avotres, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas Psoriasis Registry, Dermavant, EPI Health, Evommune, Forte Biosciences, Galderma, Genentech, Incyte, Leo Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Seanergy, Strata, Trevi, and Verrica. KH is a consultant at Bristol Myers Squibb via Syneos Health. RMK, SB, and TS are employees and shareholders at Bristol Myers Squibb. JJC is a consultant, speaker, and/or investigator at AbbVie, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Lilly, Regeneron, Sanofi, and UCB.

 

Quality of life in participants with hyperkeratotic psoriasis treated with combination halobetasol propionate/tazarotene lotion

Presenters: Stein Gold L,¹ Desai S,² Lain E,³ Jacobson A⁴

Affiliations: ¹Henry Ford Health System, West Bloomfield, MI; ²Innovative Dermatology and University of Texas Southwestern Medical Center, Plano, TX; ³Austin Institute for Clinical Research, Austin, TX; ⁴Bausch Health Companies Inc, Bridgewater, NJ

Background: Plaque psoriasis is associated with low self-esteem and negative body image.¹ Moreover, clinical symptoms caused by extensive hyperkeratosis, including plaque elevation and scaling, are associated with poor quality of life.^2,3 Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) is indicated for topical treatment of plaque psoriasis in adults.⁴ A previous post hoc analysis of two Phase 3 trials of HP/TAZ demonstrated its efficacy in the treatment of participants with severe plaque elevation or scaling.⁵

Objective: This post hoc analysis of the same participant subgroups investigated improvements in quality of life.

Methods: Participants were randomized 2:1 to receive HP/TAZ or vehicle lotion once daily for eight weeks and were evaluated at Weeks 2, 4, 6, and 8 with a 4-week follow-up at Week 12 after treatment cessation.⁶ The Dermatology Life Quality Index (DLQI) questionnaire was administered to participants at baseline, Week 4, and Week 12. Participants were grouped into two subgroups, severe plaque elevation or severe scaling, which were defined as having a baseline target score of 4 (severe) on a 0 to 4 scale for plaque elevation or scaling, respectively. Plaque elevation and scaling were scored independently; thus, subgroups were not exclusive. Outcomes measured through 12 weeks included change from baseline in mean DLQI score and DLQI success (defined as achieving a ≥4-point decrease from baseline in DLQI score or achieving a DLQI score of 0 or 1).

Results: In the pooled Phase 3 trials, 54 target plaques (HP/TAZ, n=34; vehicle, n=20) had severe plaque elevation and 57 target plaques (HP/TAZ, n=37; vehicle, n=20) had severe scaling. Participants with severe plaque elevation or scaling treated with HP/TAZ demonstrated improvements from baseline in DLQI score, with a mean change of -7.4 and -5.5, respectively, at Week 8. Improvement from baseline DLQI score was maintained at Week 12 (4 weeks posttreatment; severe plaque elevation: -7.2; severe scaling: 4.7). Furthermore, at Week 8, rates of DLQI success were numerically greater in HP/TAZ-treated participants than in vehicle-treated participants (severe plaque elevation: 77% vs 53%, respectively; severe scaling: 68% vs 47%, respectively), and this trend was maintained four weeks posttreatment. Moreover, DLQI success rates at Week 8 were greater for HP/TAZ–treated participants with severe plaque elevation than for those with mild plaque elevation (77% vs 50%, respectively; mild plaque elevation [score=2 at baseline], n=30) and greater for those with severe scaling than for those with mild scaling (68% vs 58%, respectively; mild scaling [score=2 at baseline], n=36). Participants receiving HP/TAZ with severe plaque elevation or scaling reported improvements in multiple DLQI items, including feeling embarrassed/self-conscious (Week 8, 1.3 and 1.0, respectively).

Conclusion: The high rates of DLQI success observed in the vehicle group may be attributed to the unique moisturizing formula of the HP/TAZ vehicle lotion. This post hoc analysis demonstrates that HP/TAZ may be associated with improvements in quality of life such as decreased self-consciousness in patients with hyperkeratotic psoriatic plaques (eg, severe plaque elevation or scaling).

Disclosures: LSG has served as an investigator, advisor, and/or speaker for Almirall, Galderma, Novartis, Ortho Dermatologics (a division of Bausch Health Companies Inc), Sol-Gel Technologies, Sun Pharma, and Vyne Therapeutics.SD has served as a research investigator and/or consultant for Almirall, Dermavant Sciences, Dermira, Galderma, Ortho Dermatologics (a division of Bausch Health Companies Inc), Pfizer, SkinMedica, and Watson. EL has served as an investigator, speaker, consultant, or advisory board member for AbbVie, Aclaris Therapeutics, AlfaSigma USA, Allergan, Almirall, Arcutis Biotherapeutics, AstraZeneca, Athenix, Biofrontera, Biopelle, BioPharmX, Biorasi, Brickell Biotech, Bristol-Myers Squibb, Cassiopea S.p.A, Castle Biosciences, Celgene, Cellceutix, ChemoCentryx, Concert Pharma, Cutanea, Dermavant Sciences, Dermira, Dermtech, Dow, Dr. Reddy’s Laboratories, Novan, Endo Pharma, Evelo, Gage Development Company, Galderma Laboratories L.P, Galderma USA, Hovione, Incyte, Janssen, Johnson & Johnson Services, Kadmon Corporation, La Roche-Posay, LEO Pharma, Lilly, MedImmune, Menlo Therapeutics, Mindera, Moleculin, Neothetics, Nielsen Holdings N.V, Novartis, Ortho Dermatologics (a division of Bausch Health Companies Inc), Pierre Fabre, Pfizer, Promius Pharma, Sanofi, Sebacia, Sienna Labs, SkinCeuticals, Sol-Gel Technologies, SUN Pharma, Symatese, Timber Pharma, UCB, Valeant Pharmaceuticals North America, and Vyne Therapeutics. AJ is an employee of Bausch Health Companies Inc.

Funding: This study was funded by Ortho Dermatologics. Medical writing support was provided under the direction of the authors by MedThink SciCom.

References: 

1. Nazik H, Nazik S, Gul FC. Body image, self-esteem, and quality of life in patients with psoriasis. Indian Dermatol Online J. 2017;8(5):343–346.
2. Korman NJ, Zhao Y, Pike J, et al. Increased severity of itching, pain, and scaling in psoriasis patients is associated with increased disease severity, reduced quality of life, and reduced work productivity. Dermatol Online J. 2015;21(10).
3. Nayak PB, Girisha BS, Noronha TM. Correlation between disease severity, family income, and quality of life in psoriasis: a study from south India. Indian Dermatol Online J. 2018;9(3):165–169.
4. Duobrii [prescribing information]. Bridgewater, NJ: Bausch Health Companies Inc; 2019.
5. Tanghetti E, Stein Gold L, Lain E, et al. Combination halobetasol propionate/tazarotene lotion for the treatment of psoriatic plaques with severe elevation or scaling. Abstract presented at Maui Derm NP+PA Fall Conference; September 27-30, 2023; Asheville, NC.
6. Sugarman JL, Weiss J, Tanghetti EA, et al. Safety and efficacy of a fixed-combination halobetasol and tazarotene lotion in the treatment of moderate-to-severe plaque psoriasis: a pooled analysis of two phase 3 studies. J Drugs Dermatol. 2018;17(8):855–861.

Changes in TNF-α levels in psoriatic plaques after treatment with fixed-combination halobetasol propionate and tazarotene lotion versus clobetasol propionate 0.05% cream

Presenters: Draelos Z,¹ Draelos M,¹ Jacobson A²

Affiliations: ¹Dermatology Consulting Services, High Point, NC; ²Ortho Dermatologics (a division of Bausch Health Companies Inc), Bridgewater, NJ

Background: Psoriasis is driven by inflammatory cytokines including tumor necrosis factor alpha (TNF-α).¹ Injectable biologics are often prescribed to target TNF-α and improve severe psoriatic disease,^2,3 but similar effects may be achieved with topical therapy in patients with limited disease. For instance, in a previous study, fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ; approved for treatment of plaque psoriasis in adults) was associated with reduced lesional levels of TNF-α through 12 weeks of treatment in patients with mild-to-moderate plaque psoriasis.^4,5 This reduction of TNF-α levels may be driven by the ability of tazarotene to downregulate inflammatory cytokines including TNF-α.⁶ Both tazarotene and HP/TAZ have demonstrated maintenance of therapeutic effect following treatment cessation.^7,8 However, it remains unclear if reductions in lesional TNF-α levels are maintained after HP/TAZ cessation, and if topical corticosteroid monotherapy is associated with similar reduction of proinflammatory cytokines. 

Objective: The present study compared the effects of HP/TAZ and clobetasol propionate 0.05% cream (clobetasol) on TNF-α levels in psoriatic plaques during and after treatment.

Methods: Adults with mild-to-moderate plaque psoriasis with ≥2 similar target plaques were included. Matched target plaques of each subject were randomized to receive once-daily HP/TAZ or clobetasol for four weeks. At baseline, Week 4, and Week 8 (4 weeks after treatment cessation), 10 D-squame strips (5 for analysis, 5 for backup) were removed from each target plaque for analysis by enzyme-linked immunosorbent assay (ELISA) to determine TNF-α levels. To calculate reductions in TNF-α levels from baseline, paired plaques with elevated cytokine levels at baseline (defined as ≥2x the TNF-α level detected in a nonlesional skin control) were included in the analysis. Statistical significance (P≤0.05) was determined by using a 1-tailed paired t test. Target plaques were photographed and graded individually for investigator’s global assessment (IGA) as well as erythema, induration, and scaling at each time point; P values were calculated using a 2-tailed unpaired t test. 

Results: All 10 subjects completed the study. At baseline, nine subjects were assigned two target plaques, and one subject was assigned four target plaques, totaling 22 target plaques (11 pairs). Most plaques were of moderate disease severity at baseline (IGA 2, n=8; IGA 3, n=14), and all paired plaques had identical IGA scores. At baseline, 6 of 11 paired plaques had elevated TNF-α levels and were included in the ELISA analysis. Significant and similar reductions in TNF-α levels from baseline were observed in plaques treated with HP/TAZ or clobetasol at Week 4 (mean, -69.4% and -63.3%, respectively; P≤0.001 for each). Four weeks after treatment cessation (Week 8), HP/TAZ–treated plaques maintained a significant reduction in TNF-α levels from baseline (mean, -52.7%; P<0.01). However, in clobetasol-treated plaques, TNF-α levels rebounded following treatment cessation (mean percent change from Week 4 to Week 8, +42.5%), demonstrating no significant difference from baseline (mean, -20.8%; P=0.195). Plaques with reduced TNF-α levels generally correlated with improvements in visual symptoms (captured by photography). Significant improvements in IGA score and erythema, induration, and scaling scores were reported for all plaques for both HP/TAZ and clobetasol treatments at Weeks 4 and 8 (P≤0.001 for all assessments), regardless of baseline TNF-α level. No adverse events were reported.

Conclusion: Through four weeks of treatment, both HP/TAZ and clobetasol were associated with reduced TNF-α levels in psoriatic lesions that had elevated levels at baseline. Significant reductions in TNF-α levels were maintained four weeks after treatment cessation in HP/TAZ–treated plaques but not in clobetasol-treated plaques, suggesting the superiority of HP/TAZ at reducing inflammation and maintaining disease improvement long-term. Sustained reduction of TNF-α levels by HP/TAZ is likely.

Disclosures: ZD received funding from Ortho Dermatologics to conduct the research detailed in this poster. AJ is an employee of Bausch Health Companies Inc.

Funding: This study was funded by Ortho Dermatologics. Medical writing support and editorial assistance were provided under the direction of the authors by MedThink SciCom and funded by Ortho Dermatologics. 

References:

1. Hawkes JE, Yan BY, Chan TC, Krueger JG. J Immunol. 2018;201(6):1605–1613.
2. Enbrel [prescribing information]. Thousand Oaks, CA: Amgen Inc and Pfizer Inc; 2012.
3. Infliximab [prescribing information]. Horsham, PA: Janssen Biotech, Inc; 2021.
4. Draelos ZD, Draelos MM, Lin T, Jacobson A. J Dermatolog Treat. 2023;34(1):2245081.
5. Duobrii [package insert]. Bridgewater, NJ: Bausch Health Companies Inc; 2020.
6. Lebwohl MG, Tanghetti EA, Stein Gold L, et al. Dermatol Ther (Heidelb). 2021;11(4):1157–1174.
7. Weinstein GD, Koo JYM, Krueger GG, et al. J Am Acad Dermatol. 2003;48(5):760–767.
8. Lebwohl MG, Stein Gold L, Del Rosso JQ, et al. J Dermatolog Treat. 2022;33(4):2068–2074.

A systematic literature review and meta-analysis of the real-world effectiveness, quality of life, and safety of tildrakizumab for moderate-to-severe plaque psoriasis

Presenters: Gottlieb S,¹ Farberg AS,² Bhatia N,³ Fazeli MS,⁴ Hofer K,⁴ Lam O,⁴ Barghout V,⁵ Mathew J,⁶ Ferro T⁶

Affiliations: ¹Schweiger Dermatology Group, Exton, PA, USA; ²Section of Dermatology, Baylor Scott & White Health System, Dallas, TX, USA; Bare Dermatology, Dallas, TX, USA; ³Therapeutics Clinical Research, San Diego, CA, USA; ⁴Evidinno Outcomes Research Inc., Vancouver, Canada; ⁵Viver Health, Morristown, NJ, USA; ⁶Sun Pharmaceuticals Industries Limited, NJ, USA

Background: Plaque psoriasis is a chronic, immune-mediated skin condition with a significant impact on patient quality of life. Tildrakizumab, an anti-interleukin-23 p19 monoclonal antibody, is a treatment option for patients eligible for systemic therapy.

Objective: This systematic literature review and meta-analysis (MA) was performed to evaluate the real-world effectiveness, quality of life, and safety of tildrakizumab for treatment of patients with moderate-to-severe plaque psoriasis.

Methods: MEDLINE® and Embase were comprehensively searched on November 16, 2023 to identify real-world evidence (RWE) studies, published in English, examining the effectiveness, quality of life, and safety associated with tildrakizumab in adults (aged ≥18 years) with chronic moderate-to-severe psoriasis. Key dermatology and rheumatology conferences (2021-2023) and bibliographies of previous literature reviews were also searched. Eligible study designs with RWE included cohort studies, single-arm trials, Phase IV trials, pragmatic trials and case-control studies reporting outcomes of interest for effectiveness (Psoriasis Area and Severity Index [PASI] score, Physician’s Global Assessment [PGA], affected Body Surface Area % [%BSA]), quality of life (Dermatology Life Quality Index [DLQI] score), or safety (serious adverse events [SAE], treatment-related AEs [TRAE], or withdrawals due to AEs [WDAE]). Both single-arm and comparative studies of tildrakizumab were sought, and eligible comparators included other biologics. Both tildrakizumab-only and comparative MAs were performed for frequently reported effectiveness, quality of life, and safety outcomes at grouped time points (12–16 weeks, 24–28 weeks, and 36–52 weeks); use of random effects or fixed effects MA was guided upon the degree of observed statistical heterogeneity. Subgroup analyses (geographic setting, prior biologic exposure, and presence of comorbidities) were explored.

Results: Forty-five publications pertaining to 37 unique studies from Europe and the United States formed the evidence base for MAs. Most were single-arm studies that measured outcomes for tildrakizumab, while six had multiple study groups and involved head-to-head comparisons of tildrakizumab with guselkumab (n=6 studies) and/or risankizumab (n=5). Single-arm MAs of PASI scores for tildrakizumab demonstrated a reduction in mean score from 12.81 at baseline (95% confidence interval [CI] 11.69, 13.92) to 1.62 (95%CI 1.03, 2.20) after 36–52 weeks. MAs of %BSA showed a reduction in mean value from 16.21% (95%CI 13.72, 18.70) to 3.27% (95%CI 1.26, 5.28) at 36–52 weeks. Clinically important reductions were also identified at 36–52 weeks for PGA 0/1 and DLQI (Table 1). Comparative MAs of tildrakizumab versus guselkumab and tildrakizumab versus risankizumab found no statistically significant differences at 12–16 or 24–28 weeks for PASI score and %BSA. Single-arm and comparative MAs of safety outcomes showed that SAEs, TRAEs and WDAEs were rare, decreased in risk over time, and were of similar frequency with tildrakizumab compared with guselkumab and risankizumab. Subgroup analyses were supportive of findings from primary analyses.

Conclusion: This systematic review and MA of RWE demonstrates that tildrakizumab is consistently associated with long-term effectiveness and improved quality of life, and is well tolerated in patients with moderate-to-severe plaque psoriasis. These findings are consistent with those from randomized controlled trials.

Disclosures: SG serves as a consultant, advisory board member and consultant for Janssen, Bristol Myers Squibb, UCB, Lilly and Sun Pharmaceutical Industries Limited; He receives research or educational grants from Janssen, Lilly, and Eirion. AF has been an advisor for Apogee, Amen, Boehringer Ingelheim, Bristol Myers Squibb, Castle Biosciences, Feldan, Incyte, Galderma, Janssen, Novartis, Pfizer, Regeneron, Sanofi, Ortho Dermatologics, and Sun Pharmaceutical Industries Limited. NB is an advisor, consultant, and investigator for AbbVie, Almirall, Arcutis, Beiersdorf, Biofrontera, Boehringer Ingelheim, Bristol Myers Squibb, Cara, Dermavant, EPI Health, Ferndale, Galderma, InCyte, ISDIN, Johnson & Johnson, LaRoche-Posay, LEO Pharma, Lilly, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun Pharmaceutical Industries Limited, and Verrica Pharmaceuticals, Inc. MSF, KH, and OL report employment with Evidinno Outcomes Research Inc. VB is CEO of Viver Health, LLC, which receives funding from Novartis, Bristol Myers Squibb, Sun Pharmaceutical Industries Limited, and Taiho Pharmaceutical Co. JM and TF report employment with Sun Pharmaceutical Industries Limited. 

Funding: The study and medical writing support for this abstract were funded by Sun Pharmaceutical Industries Limited.

 

 SKINCARE AND COSMECEUTICALS

Clinical evaluation of next-generation, multi-weight hyaluronic acid plus antioxidant complex-based topical formulations with targeted delivery to enhance skin rejuvenation

Presenters: Lain T,¹ Mariwalla L,² Kirchner F,³ Arrowitz C,³ Ruvolo E,³ Draelos Z,⁴ Zeichner J⁵

Affiliations: ¹Sanova Dermatology, Austin, TX; ²Mariwalla Dermatology, West Islip, NY; ³Beiersdforf Inc, Florham Park, NJ; ⁴Dermatology Consulting Services, High Point, NC; ⁵Department of Dermatology, Mount Sinai Hospital, New York, NY

Background: Hyaluronic acid (HA) has become a commonly used ingredient in many topical moisturizing products due to its strong humectant properties and essential role in skin hydration; however, limitations of delivery of HA to only the surface of skin has hindered leveraging the full capacity of HA biology necessary for skin rejuvenation. 

Objective: Here, we describe the clinical efficacy data of a set of novel next-generation, multi-weight HA plus antioxidant complex-based topical formulations with targeted skin delivery to enhance skin rejuvenation, giving a youthful, healthy appearance.

Methods: Four multi-weight HA plus antioxidant complex-based formulations: 1) Multi-Weight HA plus Antioxidant Complex Cream with SPF 30 (Day Cream); 2) Multi-Weight HA plus Antioxidant Complex Cream (Night Cream); 3) Multi-Weight HA plus Antioxidant Complex Gel Cream; and 4) Multi-Weight HA plus Antioxidant Complex Boost Serum were clinically evaluated for key attributes including moisturization via Corneometer, clinical grading of: dryness, roughness, fine lines and wrinkles, and following daily use of the individual products for up to eight weeks. 

Results: Daily use of the multi-weight HA plus antioxidant complex-based formulations demonstrated significant improvements in all parameters evaluated compared to baselines, with changes in moisturization observed within 30 minutes of application, and changes in clinical grading parameters of dryness, roughness, fine lines, and wrinkles observed as early as two weeks.

Conclusion: These data demonstrate the clinical benefits of daily use of multi-weight HA plus antioxidant complex-based moisturizers for overall improvement in skin health and appearance.

Funding: Funding was provided by Beiersdorf Inc.

 

Significantly enhanced improvement in dryness, roughness, fine lines and radiance following daily use of a novel multi-weight plus antioxidant complex-based lotion compared to a single-weight HA plus ceramide-based lotion

Presenters: Lain T,¹ Mariwalla K,² Kirchner F,³ Arrowitz C,³ Ruvolo E,³ Draelos Z,⁴ Zeichner J⁵

Affiliations: ¹Sanova Dermatology, Austin, TX; ²Mariwalla Dermatology, West Islip, NY; ³Beiersdforf Inc, Florham Park, NJ; ⁴Dermatology Consulting Services, High Point, NC; ⁵Department of Dermatology, Mount Sinai Hospital, New York, NY

Background: Hyaluronic acid (HA) has become a commonly used ingredient in many topical moisturizing products due to its strong humectant properties and essential role in skin hydration; however, limitations of delivery of HA to only the surface of skin has hindered leveraging the full capacity of HA biology necessary for skin rejuvenation.

Objective: Here, we describe the head-to-head clinical comparison of a novel multi-weight HA plus antioxidant complex-based lotion with SPF 30 and a single-weight plus ceramide-based lotion with SPF 30 for clinical efficacy on dryness, roughness, fine facial lines, and radiance following daily use.

Methods: A double-blind comparative study was conducted on 70 female subjects (n=35, multi-weight HA plus antioxidant complex-based cream with SPF 30; n=35, ceramide-based cream with SPF 30) ages 25 to 65 years with mild to moderate facial dryness and visible fine lines and wrinkles, including subjects with Fitzpatrick Skin Types I-VI, with 20 percent having Fitzpatrick Skin Types V–VI. Clinical grading of the face including dryness, roughness, fine lines were assessed at baseline, 30 minutes, 2 weeks, 4 weeks, and 8 weeks after once daily application in the morning. Visible, cross-polarized (X-POL), parallel-polarized (PPOL) and UV fluorescence clinical images were acquired for each time point. X-Pol and P-Pol images were used to quantify skin radiance.

Results: Daily use of the multi-weight HA plus antioxidant complex-based lotion with SPF 30 demonstrated significant improvements in all clinical grading assessments of dryness, fine lines, and wrinkles as early as Week 2 compared to baseline. Improvements in visible dryness (Week 2), roughness (Week 2), and fine lines (Week 8) were greater for the multi-weight HA plus antioxidant complex-based lotion with SPF 30 compared to the single-weight HA plus ceramide-based cream with SPF 30, with overall statistical significance across all three parameters assessed favoring the multi-weight HA plus antioxidant complex-based cream with SPF 30. For radiance, daily use of multi-weight HA plus antioxidant complex-lotion with SPF 30 demonstrated significant increase in radiance at Week 4 compared with baseline, while the single HA plus ceramide-based lotion did not show any improvement in skin radiance compared with baseline.

Conclusion: The marked improvements in dryness, roughness, fine lines, and radiance following daily utilization of the multi-weight HA plus antioxidant complex-based lotion with SPF 30 may be attributed to the inherent properties of HA. These improvements may be further attributed to the ability of multi-weight HAs to moisturize the skin surface and penetrate the upper surface layers of the skin, combined with the added benefits of key antioxidants, including glycine saponin and glycyrrhetinic acid, which have been previously shown to induce endogenous HA synthesis and inhibit endogenous hyaluronidase activity in vitro, respectively.

Funding: Funding was provided by Beiersdorf Inc.

 

A multi-action facial night cream containing Macrocystis pyrifera ferment and extracts from Crithmum maritimum and Laminaria digitata delivers ageless benefits over night and over time 

Presenters: DiNatale L,^1,2 Zhao X,³ Wang S,³ Michelle P,² Schmidt L,² Santhanam U^1,2

Affiliations: ¹La Mer, Max Huber Research Labs, Melville, New York, USA; ²Research & Development, The Estée Lauder Companies, Melville, New York, USA; ³APAC Innovation Lab, The Estée Lauder Companies, Shanghai 201203, PR China.

Background: Over time, facial skin is characterized by the presence of fine lines, wrinkles, and the loss of firmness and elasticity, among other alterations in its appearance due to aging and environmental exposure. Inflammation plays a significant role in this process, contributing to the degradation of extracellular matrix proteins, a decrease in hydration, a weakened barrier, and a reduction in epidermal cell renewal. While these changes develop over many years, consumer demand is for rapid and tangible improvement through aggressive treatments such as retinol, despite the potential risk of skin damage. 

Objective: A novel topical preparation designed for use at night with multifaceted benefits has been developed using a unique bioactive technology. This night cream is shown in a series of clinical trials to start by delivering visible improvement overnight while it helps rebuild skin strength in the longer term.

Methods: A complex of three marine sourced extracts, consisting of microcondensates of totipotent cells isolated from Crithmum maritimum, a supercritical CO₂ wax extract of C. maritimum, and Laminaria digitata extract, hereinafter referred to as the marine complex, was developed with the aim of offering similar benefits to retinol. Together with Macrocystis pyrifera (MP) ferment, previously demonstrated to provide significant anti-irritation benefits,¹ a formulation was developed and tested in several clinical studies, conducted in both the United States and China.

Results: From the first night of application, MPF-containing night cream was shown in a clinical study to deliver improvement in the appearance of fine lines and wrinkles. Additionally, it provided skin moisture, resulting in softer, smoother, and plumper skin. Furthermore, it exhibited eight hours of antioxidant activity. Over time, the studies demonstrated cell renewal benefits and improved barrier resilience. This night cream was well positioned to deliver long-term skin improvements, including firmness, visible reduction of lines and wrinkles, and increases in skin smoothness while also being appropriate for all skin types including sensitive skin.

Conclusion: The night cream formulated with the marine complex and Macrocystis pyrifera ferment is demonstrated to provide improvement in skin appearance overnight and over time without negative side effects as frequently observed with retinol use.

References:

1. Gold et al, J Cosmet Dermatol. 2023.

A complex of three marine extracts exhibits “retinol-like” anti-aging mechanisms without stimulating an acute inflammatory response

Presenters: Emmetsberger J^1,2 and Ortiz A²

Affiliations: ¹La Mer, Max Huber Research Labs, Melville, New York, USA; ²Research & Development, The Estée Lauder Companies, Melville, New York, USA.

Background: Retinol’s clinically demonstrated anti-aging benefits can be partially attributed to its enhancement of collagen, glycosaminoglycans and cellular turnover. However, instability and propensity to induce irritation and retinol dermatitis in sensitive skin types and with initial application can limit retinol use.

Objective: We sought to determine if a complex of three marine sourced extracts, consisting of microcondensates of totipotent cells isolated from Crithmum maritimum, a supercritical CO₂ wax extract of C. maritimum, and Laminaria digitata extract, hereafter referred to as marine complex, could have “retinol-like” properties without contributing to associated irritation.

Methods: Reconstructed living skin equivalents (LSEs) and ex vivo skin, isolated from panniculectomies, were treated topically with the marine complex or retinol, and immunochemical techniques and histological evaluation were employed to address if the marine complex had similar downstream effects as retinol. The quantitative expression of cellular retinoic acid binding protein-II (CRABP-II), IL-1α, TNF-α, and GM-CSF were evaluated by ELISA. The expression of collagen, glycosaminoglycans and filaggrin were assessed via immunohistochemistry (IHC) and general skin morphology by H&E staining. 

Results: To establish if the marine complex could influence endogenous retinoic acid signaling, CRABP-II levels were assessed using tissue homogenates from ex vivo skin that were treated for 48 hours with either 0.1% retinol or the marine complex. The marine complex significantly upregulated CRABP-II levels comparable to the retinol treatment. Given that CRABP-II contributes to intracytoplasmic retinoid trafficking and regulates epidermal proliferation and differentiation, we explored if the marine complex could alter epidermal morphology in LSEs after seven days. H&E staining revealed vacuolar fluid-filled keratinocytes and pyknotic nuclei with retinol treatment, suggestive of acute irritation associated with the retinization process. LSEs treated with the marine complex exhibited normal cellular and nuclear morphology along with an enhancement of the epidermal living layer compared to the vehicle control. In ex vivo models, the marine complex increased collagen type-1 and glycosaminoglycan IHC signals, an extensively reported observation of retinol treatment. Retinol is also known to negatively regulate filaggrin and increase the expression proinflammatory cytokines IL-1α, TNF-α, and GM-CSF which can be contributing factors in skin dryness and irritation, respectively. In LSEs, retinol reduced filaggrin expression in the keratohyalin granules while the marine complex maintained expression similar to the vehicle control. Cytokine analysis revealed that unlike retinol, TNF-α, and GM-CSF were not significantly altered and IL-1α was significantly reduced compared to the vehicle control.

Conclusion: These data suggest the marine complex promotes several similar anti-aging mechanisms as retinol treatment without associated irritation.

 

Evaluation of a skincare regimen comprised of a serum containing plant adaptogens and a cream addressing three components of moisturization pre- and post-laser treatment or a medium-depth chemical peel

Presenters: Watchmaker J¹ and Nelson DB²

Affiliations: ¹Southwest Skin Specialists, Scottsdale, AZ; ²skinbetter science, Phoenix, AZ

Background: Integrating skincare products prior to and following cosmetic procedures helps support skin quality and optimize patient outcomes.

Objective: Evaluate tolerability and efficacy utilizing a serum comprised of plant adaptogens (MYS-ABS), developed to support skin’s response to stress, in combination with a cream that addresses three components of natural moisturization (TRIO-L) pre- and post-laser or a medium-depth chemical peel.

Methods: A single-center, open-label trial was conducted in participants between the age of 25–65 years old, FST I–IV with mild-to-moderate photodamaged skin. Participants applied MYS-ABS and TRIO-L twice-daily, 2 weeks pre- and 4 weeks post-procedure (TRIO-L was applied as needed, through Day 7). Participants were randomized to receive a single fractional laser treatment (Fraxel® 1927, 10 mJ, 35-40% [FST I=III] or 20-30% [FST IV], 8 passes), or a medium-depth TCA chemical peel (VI Peel Original). The study investigator and participants assessed tolerability using a 4-point grading scale (0=None to 3=Severe) approximately five minutes post-procedure, and on Days 1, 2, 4, and 7. Investigator assessment of global skin quality occurred at baseline, 2 weeks (pre-procedure), and 4 weeks (post-procedure) utilizing the Global Skin Quality Index (GSQI; total sum of scores combined using 6-point grading scales [0=None to 5=Very Serve] for erythema, skin dullness, skin texture [visual roughness], pore size and uneven pigmentation). Adverse events (AEs) were captured throughout the study.

Results: Nineteen female participants completed the study; ten underwent fractional laser treatment and nine received a medium-depth chemical peel. The mean age was 50 years; 84 percent of participants were FST II, 16 percent were FST IV (combined groups). All AEs were temporary, anticipated, and related to the procedures. In the laser group, mean investigator assessed erythema and edema peaked on Day 1 (1.5 and 1.8, respectively) with dryness/flaking peaking on Day 2 (1.7) with all nearly resolved by Day 7. In the chemical peel group, mean erythema and dryness/flaking peaked on Day 2 (1.2 and 1.8, respectively), nearly resolving by Day 7 with no observed edema. Mean participant reports of warmth, redness, and stinging/tingling were greatest immediately following the laser procedure (2.1, 1.8, and 1.6, respectively), all nearly resolving by Day 7. Dryness/flaking was described as moderate on Days 2 and 4, and mild on Day 7. In the chemical peel group, mean highest participant reported events were dryness/flaking (Day 2), redness (Day 0), tightness (Days 3 and 4), and itching (Day 4; 2.2, 1.4, 1.3, and 1.2, respectively), with all events nearly resolving by Day 7. Significant mean improvements from baseline in global skin quality occurred in the both the laser and chemical peel groups 2-weeks pre-procedure (12% and 15%, respectively [p=0.004, each]) and 4-weeks post procedure (41% and 40%, respectively [p<0.0001, each]).

Conclusion: A skincare regimen utilizing a serum comprised of plant-based adaptogens and a cream addressing three components of moisturization prior to and following a single fractional laser treatment or a medium-depth chemical peel, was highly tolerable with only temporary, anticipated, and procedurally related AEs occurring. Significant improvements from baseline in global skin quality were demonstrated 2 weeks prior to and 4 weeks following each procedure.

Disclosures: JW was the study investigator, and DN is an employee of skinbetter science.

Funding: This study was funded by skinbetter science, LLC.

 

Evaluation of a new moisturizer developed to address three critical elements of natural moisturization in participants with moderate-to-severe dry, dehydrated facial skin

Presenters: Draelos Z¹ and Nelson DB² 

Affiliations: ¹Dermatology Consulting Services PLLC, High Point, NC; ²skinbetter science, Phoenix, AZ

Background: Balanced skin health encompasses three critical elements of natural moisturization including hyaluronic acid, natural moisturizing factors, and lipids (essential fatty acids, ceramides, and cholesterol). A new, emollient-rich moisturizing cream (TRIO-L) has been developed to address these elements.

Objective: This study evaluated its effects on hydration, satisfaction, and tolerability in participants with dry, dehydrated facial skin.

Methods: A single-center, open-label trial was conducted in participants bewteen the age of 50 and 70 years old, FST I–VI with moderate-to-severe dry, dehydrated facial skin. Participants applied TRIO-L twice-daily for eight weeks, and a gentle cleanser and sunscreen. Skin hydration was assessed utilizing instrumentation (Corneometer, Cortex Technology, Hadsund Denmark) at Baseline, 2, 4, and 8 weeks. Participants completed self-assessment questionnaires 30 minutes after initial application and at 2, 4, and 8 weeks. Digital images and Adverse Events (AEs) were captured throughout the study period.

Results: Twenty-seven female participants were enrolled and completed the study. Mean age was 62 years; 78 percent of participants were Caucasian, 18 percent were African American, and 96 percent were non-Hispanic. Seventy-four percent of participants were FST I–II, 7 percent were FST III, and 19 percent were FST V–VI. Following initial application, 100 percent of participants reported TRIO-L absorbed nicely and had a pleasant texture/feel; 96 percent reported that their skin felt softer and 89 percent reported their skin looked replenished, less dry and healthier. After two weeks, 96 percent noted smoother-looking skin texture and improvements in overall appearance. After eight weeks, 100 percent of participants reported that their skin looked younger and healthier, with smoother texture and less noticeable fine lines/wrinkles, and 96% reported their skin felt deeply hydrated and nourished. Significant mean percent improvements from baseline were demonstrated in skin hydration measurements at Week 2 (41%; p<0.0001), Weeks 4 (38%; p<0.0001) and 8 (116%; p<0.0001). All AEs were transient and mild. No participant discontinued use of study product owing to an AE.

Conclusion: Twice-daily use of a new, emollient-rich moisturizing cream developed to support three critical elements of natural moisturization including hyaluronic acid, natural moisturizing factors, and lipids led to significant increases in skin hydration from baseline over eight weeks. Study participants reported healthier-looking, hydrated skin. The study product was well tolerated with mild, transient AEs reported. 

Disclosures: ZD was the study investigator, and DN is an employee of skinbetter science.

Funding: This study was funded by skinbetter science, LLC.

 

Real-world clinical experience with a neuro-peptide serum in combination with neurotoxin injectables

Presenters: Lupin M,¹ Bjerring P,² Andriessen A,³ Chantrey J,⁴ Fabi S,⁵ Liew S,⁶ McDonald C,⁷ Xiaolei A,⁸ White S⁹

Affiliations: ¹Cosmedica Laser Centre, Victoria, BC, Canada; ²Department of Dermatology, Aalborg University Hospital, Aalborg, Denmark; ³Radboud UMC Nijmegen, Andriessen Consultants, Malden, NL.; ⁴ØNE aesthetic studiø, Alderley Edge, Cheshire, UK; ⁵Cosmetic Laser Dermatology, San Diego; University of California, San Diego, CA; ⁶Shape clinic, Medical Director, Specialist Plastic Surgeon, Sydney Australia. ⁷St Vincent’s Hospital, Director Complete Skin Specialists, Sunbury, Melbourne, Australia. ⁸DEYI SKIN Dermatology Clinic, Shenzhen, China; ⁹SkinCeuticals, New York, New York

Background: We evaluated real-life experiences of a topical serum containing 2% acetyl hexapeptide-8, 2% dipeptide diaminobutyroyl, 5% PHA, 5% niacinamide, and 1% laminaria extract. The serum works via a synergistic action by stimulating nine key skin biomarkers to reduce wrinkles and produce a skin-brightening effect. Studies have shown that neuropeptides can effectively treat facial rhytids.^1,2 

Objective: Here, we highlight real-life experiences using an integrated skincare regimen consisting of BTXA (botulinum toxin type-A) injection in conjunction with twice daily topical neuro-peptide serum.

Methods: Five dermatologists and two surgeons with expertise in cosmetic procedures were selected for an advisory board. Experts were chosen from various practice settings and geographical locations to capture diverse perspectives. During the meeting, the experts were asked to share patient cases in which an integrated skincare regimen containing neuro-peptide serum and BTXA injections were used. Each expert presented two cases of patients who were greater than 30 years old who received BTXA injections followed by twice daily use of neuro-peptide serum. Treatment goals, challenges, and patient outcomes were discussed in each of the presented cases.

Results: Expert physicians selected four cases to highlight an integrated skincare regimen for BTXA injection patients and provide clinical pearls that may guide future treatment algorithms. Case 1: Neuromodulator-Experienced Patient Treated with Azzalure® (abobotulinumtoxinA) in combination with neuro-peptide serum Case 2: Previous adverse effects with Botox® (onabotulinumtoxinA). 46-year-old woman, Fitzpatrick Skin Type III tolerated neuro-peptide serum and reported improvement in fine lines. Case 3: Reduction in pore size in a 40-year-old male, Fitzpatrick Skin Type IV with use of Botox® and neuro-peptide serum combination. Case 4: Improvement of crow’s feet, dynamic wrinkles, and photoaged skin in a 43-year-old male, Fitzpatrick Skin Type II with use of Dysport® (abobotulinumtoxinA) and neuro-peptide serum.

Conclusion: Real-world cases provide evidence for combination treatments that may be used in cosmetic dermatology to improve patient outcomes and satisfaction. Neuro-peptide serum appears to complement BTXA injections to improve radiance, reduce fine lines and reduce wrinkles in a diverse set of patients. Incorporating neuro-peptide serum into integrated skincare regimens may offer an additive effect to BTXA injections and ultimately, optimize patient results.

Funding: An unrestricted educational grant was provided by SkinCeuticals, International.

References:

1. Araco A and Francesco, A. (2021). Prospective randomized clinical study of a new topical formulation for face wrinkle reduction and dermal regeneration. J Cosmet Dermatol. 2021 Sep;20(9):2832–2840.
2. Lungu C, Considine E, Zahir S, et al. Pilot study of topical acetyl hexapeptide-8 in the treatment for blepharospasm in patients receiving botulinum toxin therapy. Eur J Neurol. 2013 Mar;20(3):515–518.

Snail extract for skin: A review of uses, projections, and limitations

Presenters: Singh N,¹ Brown AN,² Gold MH²

Affiliations: ¹University of Tennessee Health Science Center, Memphis, Tennessee, USA; ²Gold Skin Care Center, Tennessee Clinical Research Center, Nashville, Tennessee, USA

Background: Snail mucin is becoming increasingly popular for its wide range of ingredients and potential benefits. Snail extract’s widespread appearance in cosmetic formulations encourages an investigation into the medical and cosmetic benefits. This study aims to explore current literature on the variety of snail mucin applications.

Objective: We present a review of the uses, global market estimates and projects, and limitations to snail mucin.

Methods: A literature search was conducted on PubMed reviewing snail mucin and their application in medical and dermatologic fields examining their uses. Economic reports were also investigated for Global Market estimates.

Results: The therapeutic use of snail mucin in medical fields has been studied as antimicrobial agents, drug delivery vehicles, antitumor agents, wound healing agents, and biomaterial coatings among others. Additionally, the use in cosmetic fields includes antiaging, hydrating, anti-acne, scarring, and hyperpigmentation treatments. It is important to highlight that most studies conducted were preclinical or small clinical studies, stressing the need for additional large-scale clinical trials to support these claims. Investigations into the global market found estimates ranging from $457 million to $1.2 billion with upward projections in the upcoming decade. Limitations include ethical habitats for collection, allergy investigation, and missing clinical studies. 

Conclusion: The findings presented here emphasize the expanding uses of snail mucin and its ingredients alongside a growing market cosmetic industry should consider. We also emphasize the need for appropriate clinical trials into the stated benefits of snail mucin to ensure consumer safety and ethical extraction of mucin.

References: 

1. Singh N, Brown AN, Gold MH. Snail extract for skin: A review of uses, projections, and limitations. J Cosmet Dermatol. 2024 Apr;23(4):1113–1121.

The use of Aquaphilus dolomiae ferment filtrate recovery cream with topical corticosteroids, a potential option to mitigate concerns for dermal thinning and barrier disruption

Presenters: Lal K,¹ Doat G,² Stennevin A,² Barry C²

Affiliations: ¹Affiliated Dermatology; ²Pierre Fabre Dermo Cosmétique, Toulouse

Background: The use of topical corticosteroids in dermatology for treating inflammatory skin conditions and the associated risk of adverse effects is well established. Steroid phobia is a growing concern for both patients and healthcare providers due to negative effects such as epidermal thinning and barrier disruption. Aquaphilus dolomiae ferment filtrate, a novel biotechnological ingredient derived from non-pathogenic, highly flagellated bacteria demonstrated in vitro stimulatory effects on keratinocyte migration and fibroblast proliferation. Evaluation of a cream containing the postbiotic was evaluated ex vivo to determine protective effects on the skin barrier under stressed conditions and collagen sparing effects when used concurrently with a topical corticosteroid. Results indicate a potential adjunctive therapy for use with topical corticosteroids to mitigate the concern for epidermal thinning and barrier disruption. The introduction of topical corticosteroids (TC) by Sulzberger and Witten in 1952 is considered to be the most significant landmark in the history of therapy of dermatological disorders.¹ At the same time, steroid use has been associated with atrophic changes affecting both epidermis and dermis. Microscopic degenerative changes in epidermis are evident following 3 to 14 days of treatment. Initially epidermis becomes thin due to reduction in epidermal cell size, which reflects a decreased metabolic activity. After prolonged exposure there is a reduction in cell layers, that is, stratum granulosum disappears and stratum corneum becomes thin. Synthesis of stratum corneum lipids and keratohyalin granules and formation of corneodesmosomes (required for structural integrity of stratum corneum) are suppressed.^1,3,4 A questionnaire-based study of 200 dermatology outpatients with atopic eczema (age range 4 months to 67.8 years) was conducted to assess the prevalence and source of topical corticosteroid phobia. The most frequent cause for concern was the perceived risk of skin thinning (34.5%).² Some studies have shown, topical corticosteroids, despite their ability to decrease inflammation through several mechanisms, induce abnormalities in lipid synthesis and intercellular bilayer structure in the stratum corneum, which appear to prolong epidermal barrier recovery.⁵ Topical steroids application can lead to subtle changes in the epidermal barrier as observed by decreased formation of lipid lamellar bodies and delayed barrier recovery. This effect theoretically may worsen barrier impairment in atopic dermatitis and psoriasis.¹ Aquaphilus dolomiae ferment filtrate, a novel biotechnological ingredient derived from nonpathogenic, highly flagellated bacteria demonstrated in vitro stimulatory effects on keratinocyte migration and fibroblast proliferation. Due to the mechanism of action, it was hypothesized that a cream containing this postbiotic ingredient would have protective effects of the skin barrier and potential collagen sparing effects when used concurrently with a topical corticosteroid.

Objective: The objective of two ex vivo studies was to evaluate the barrier protective benefits of a restorative cream containing Aquaphilus dolomiae ferment filtrate and the collagen sparing effects of the cream when used concurrently with a topical corticosteroid.

Methods: Sodium Dodecyl Sulfate stress on the skin is known to induce a permeabilization of the skin barrier. This ex vivo study was evaluating the penetration of Lucifer Yellow to determine protective effect. Three models of human skin explants were each treated with 10% Sodium Dodecyl Sulfate. Quantification of the penetration of Lucifer Yellow (LY) in the different layers of the Stratum Corneum (SC) were evaluated on non-treated skin, Sodium Dodecyl Sulfate stressed skin with no treatment, Sodium Dodecyl Sulfate stressed skin treated with a cream not containing Aquaphilus dolomiae ferment filtrate and Sodium Dodecyl Sulfate stressed skin treated with a restorative cream containing Aquaphilus dolomiae ferment filtrate. Six human skin explant models were stressed with the topical application of a topical corticosteroids (4x 2mg/cm² Diprosone®) at Days 0, 1, 3 and 5. A topical treatment with the Aquaphilus dolomiae ferment filtrate restorative cream was applied daily (15x 2mg/cm²). A morphometric evaluation was conducted with Sirius Red staining to visualize and assess collagen fibers in the tissue section of skin before corticosteroid stress, with corticosteroid stress and corticosteroid stress with a daily application of the Aquaphilus dolomiae ferment filtrate restorative cream.

Results: Aquaphilus dolomiae ferment filtrate restorative cream significantly reduced the penetration of Lucifer Yellow in the layers of the stratum corneum by 66 percent indicating a protective effect on the skin barrier. Aquaphilus dolomiae ferment filtrate restorative cream significantly increased the total quantity of collagen based on migration substrate quality after treatment with topical corticosteroids with an increase of 71 percent compared to corticosteroids alone.

Conclusion: The inflammatory benefits of topical corticosteroids for inflammatory skin disorders are undisputed. With a rising concern of the potential negative effects, there is a concerted effort among many healthcare providers to reduce reliance of topical corticosteroid use when clinically appropriate. Given the risk and concern of epidermal thinning and barrier disruption, early studies indicate the potential use of an Aquaphilus dolomiae ferment filtrate restorative cream in conjunction with topical corticosteroids might mitigate some of the negative effects. This initial data is promising and indicates the need for further studies.

Disclosures: KL has served as a consultant or speaker for Abbvie, Pfizer, Lilly, Incyte, Sanofi, Dermavant, Arcutis, Boehringer Ingelheim. GD, AS, CB are all employees of Pierre Fabre.

Funding: This study was supported by Pierre Fabre Dermo Cosmétique, Toulouse.

References: 

1. Coondoo A, Phiske M, Verma S, et al. Side-effects of topical steroids: A long overdue revisit. Indian Dermatol Online J. 2014 Oct;5(4):416–425. 
2. Charman CR, Morris AD, Williams HC. Topical corticosteroid phobia in patients with atopic eczema. Br J Dermatol. 2000 May;142(5):931–936. 
3. Berth-Jones J. Topical therapy. In: Burns T, Breathnach S, Cox N, Griffiths C, editors. Rooks Textbook of Dermatology. 8th ed. 73. Vol. 1. UK: Blackwell Science Ltd; 2010. pp. 1–73. 
4. Srinivas CR, Lakshmi C. Principles of topical therapy in dermatology. In: Valia RG, Valia AR, editors. IADVL Textbook of Dermatology. 3rd ed. Vol. 2. Mumbai, India: Bhalani Publishing House; 2008. pp. 1591–618. 
5. Del Rosso JQ, Cash K. Topical corticosteroid application and the structural and functional integrity of the epidermal barrier. J Clin Aesthet Dermatol. 2013 Nov;6(11):20–27.